Medical Affairs Department, PregLem/Gedeon Richter, Geneva, Switzerland.
Stockholm IVF AB, Stockholm, Sweden.
Expert Opin Drug Deliv. 2021 May;18(5):643-654. doi: 10.1080/17425247.2021.1863944. Epub 2020 Dec 27.
: This user experience study evaluated the suitability of single-use versus multi-dose follitropin alfa pen injectors for self-administration by women undergoing fertility treatment.: Twenty-four fertility patients and 19 specialist nurses were recruited in four European countries to assess their use of Bemfola (a single-use pen), Gonal-f®, and Ovaleap® (multi-use pens). Participants completed usability tests in which their performance in assembling and administering doses of each pen was assessed against defined critical steps for ensuring safe and correct administration.: Critical error rates among nurses were 4%, 40%, and 49% for Bemfola®, Ovaleap®, and Gonal-f®, respectively; and among patients were 7%, 16%, and 38%. The most frequently reported critical errors occurred with the multi-use pens and were incorrect/lack of priming and failure to check the dose window prior to setting a new dose. The need to 'top up' doses from a new pen or cartridge when a pen contained insufficient dose also caused errors. The single-use pens did not cause these errors. Overall, 63% of nurses and 67% of patients had most confidence in Bemfola® for correct dosing and self-administration.: Single-use pens require fewer preparation and administration steps than multi-use pens and are associated with fewer critical handling errors.
这项用户体验研究评估了单次使用和多次使用的卵泡刺激素阿尔法笔式注射器在接受生育治疗的女性中自我给药的适用性。在四个欧洲国家招募了 24 名生育患者和 19 名专科护士,以评估他们对 Bemfola(一次性笔)、Gonal-f®和 Ovaleap®(多次使用笔)的使用情况。参与者完成了可用性测试,根据确保安全正确给药的规定关键步骤,评估了他们组装和给药每个笔的性能。护士的关键错误率分别为 Bemfola®、Ovaleap®和 Gonal-f®的 4%、40%和 49%;而患者的关键错误率分别为 7%、16%和 38%。最常报告的关键错误发生在多用途笔上,包括不正确/缺乏预充注和在设定新剂量之前未检查剂量窗口。当笔中的剂量不足时,需要从新笔或笔芯中“补充”剂量也会导致错误。这些错误不会出现在一次性笔上。总的来说,63%的护士和 67%的患者对 Bemfola®在正确给药和自我给药方面最有信心。单次使用的笔需要的准备和给药步骤比多次使用的笔少,并且与更少的关键处理错误相关。